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| Product NDC Code | 83602-123 | ||||
|---|---|---|---|---|---|
| Drug Name | Menthol overnight pain relief gel-patch |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | PATCH | ||||
| RxCUI drug identifier | 853276 | ||||
| Application Number | M017 | ||||
| Labeler Name | Guangzhou Liuquanmiao Import & Export Trade Co., Ltd. | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Menthol 4% ...... Purpose: Topical analgesic
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions Adult and Children above 12 years old: ■ Clean and dry the affected area. ■ Tear off the protective film and apply the exposed part of the patch to the affected area. ■ Carefully remove remaining film while pressing the patch firmly on the skin. ■ Remove patch from the skin after at most 8-hour application. Children under age of 12: Consult a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Benzalkonium Chloride, Carboxymethylcellulose Sodium, Dihydroxyaluminum Aminoacetate, Edetate Disodium, Glycerin, Kaolin, Lauralkonium Chloride, Lavender Essential Oil, L-Tartaric Acid, Mineral Oil, Petrolatum, Polyacrylic Acid, Polysorbate 80, Propylene Glycol, PVP, Sodium Polyacrylate, Titanium Dioxide, Water
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses Temporarily relieves muscle soreness and minor joint pains in the wrist, knees, back, neck, hips, shoulders, elbows.
Purpose
Information about the drug product’s indications for use.Purpose Topical Analgesic
Spl product data elements
Usually a list of ingredients in a drug product.Menthol Overnight Pain Relief Gel-Patch Menthol BENZALKONIUM CHLORIDE CARBOXYMETHYLCELLULOSE SODIUM WATER LAURALKONIUM CHLORIDE LAVENDER OIL KAOLIN TARTARIC ACID DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS PROPYLENE GLYCOL POLYACRYLIC ACID (250000 MW) SODIUM POLYACRYLATE (2500000 MW) TITANIUM DIOXIDE MINERAL OIL POLYSORBATE 80 GLYCERIN EDETATE DISODIUM PETROLATUM POVIDONE K90 MENTHOL MENTHOL
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Package label. Principal display panel 123-15 patch
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use ■ on wounds or damaged skin ■ with a heating pad or device ■ with other ointments, creams, sprays, or liniments ■ if you are allergic to any ingredients of this product
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.KEEP OUT OF REACH OF CHILDREN. If swallowed accidentally, get medical help or contact with Poison Control Center immediately.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or Comments: [email protected]
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if ■ skin reactions such as redness, swelling, blistering or other discomfort occur ■ symptoms persist for more than 7 days
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product ■ use only as directed ■ avoid contact with the eyes, mucous membranes or rashes ■ do not bandage tightly
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before use.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings For external use only
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API